Impact of PIF, Inhalation Technique and Medication Adherence on Health Status and Exacerbations in COPD: Protocol of a Real-World Observational Study (PIFotal COPD Study)

Marika Leving; Hans Wouters; Alberto de la Hoz; Sinthia Bosnic-Anticevich; Richard Dekhuijzen; Asparuh Gardev; Federico Lavorini; Jiska Meijer; David Price; Miguel Román Rodríguez; Ioanna Tsiligianni; Omar Usmani; Birgit Wijnsma; Janwillem Kocks

doi:10.1007/s41030-021-00172-7

Impact of PIF, Inhalation Technique and Medication Adherence on Health Status and Exacerbations in COPD: Protocol of a Real-World Observational Study (PIFotal COPD Study)

Pulm Ther. 2021 Dec;7(2):591-606. doi: 10.1007/s41030-021-00172-7. Epub 2021 Sep 17.

Authors

Marika Leving¹, Hans Wouters², Alberto de la Hoz³, Sinthia Bosnic-Anticevich^{4

5}, Richard Dekhuijzen⁶, Asparuh Gardev³, Federico Lavorini⁷, Jiska Meijer², David Price^{8

9}, Miguel Román Rodríguez¹⁰, Ioanna Tsiligianni¹¹, Omar Usmani^{12

13}, Birgit Wijnsma², Janwillem Kocks^{2

8

14}

Affiliations

¹ General Practitioners Research Institute, Professor Enno Dirk Wiersmastraat 5, 9713 GH, Groningen, The Netherlands. marika@gpri.nl.
² General Practitioners Research Institute, Professor Enno Dirk Wiersmastraat 5, 9713 GH, Groningen, The Netherlands.
³ Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
⁴ Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.
⁵ Sydney Local Health District, Sydney, Australia.
⁶ Radboud University Medical Center, Nijmegen, The Netherlands.
⁷ Department of Experimental and Clinical Medicine, Careggi University Hospital, Florence, Italy.
⁸ Observational and Pragmatic Research Institute, Singapore, Singapore.
⁹ Division of Applied Health Sciences, Centre of Academic Primary Care, University of Aberdeen, Aberdeen, UK.
¹⁰ Primary Care Respiratory Research Unit, Instituto de Investigación Sanitaria de Baleares (IdISBa), Palma, Spain.
¹¹ Health Planning Unit, Department of Social Medicine, Faculty of Medicine, University of Crete, Heraklion, Greece.
¹² National Heart and Lung Institute (NHLI), Imperial College London, London, UK.
¹³ Royal Brompton Hospital, London, UK.
¹⁴ University Medical Center Groningen, GRIAC Research Institute, University of Groningen, Groningen, The Netherlands.

Abstract

Introduction: Dry powder inhalers (DPIs), a commonly prescribed inhaler type for respiratory diseases, require patients to generate sufficient peak inspiratory flow (PIF) to ensure optimal drug delivery to the airways. Effectiveness of therapy also requires a good inhalation technique and adequate medication adherence. For patients with chronic obstructive pulmonary disease (COPD), recent studies conducted in tertiary care suggest that DPI users with suboptimal PIF have poorer COPD-related health status and increased exacerbation risk versus those with optimal PIF. The PIFotal study will investigate the impact of PIF, inhalation technique and medication adherence on patient-reported outcomes in patients with COPD in primary care using a DPI for their maintenance therapy.

Methods and analysis: This cross-sectional observational study will assess 1200 patients (aged ≥ 40 years, diagnosed with COPD and using a DPI for COPD maintenance therapy for ≥ 3 months) from the Netherlands, Spain, Portugal, Poland, Greece and Australia. Assessments will consist of (1) PIF measurements (usual patient inhalation manoeuvre, maximal PIF against resistance of own inhaler, and maximal PIF against low resistance); (2) Clinical COPD Questionnaire (CCQ), COPD Assessment Test and Test of Adherence to Inhalers scores; and (3) video recordings of patient inhalation technique. Dependent variables include health status (CCQ score), number of self-reported exacerbations in previous 12 months, and healthcare resource utilisation in previous 6 months. Independent variables include PIF values, inhalation technique errors, medication adherence, and demographic and clinical characteristics. In the primary analysis, the mean difference in CCQ score between patients (1) with optimal/suboptimal PIF, (2) exhibiting/not exhibiting inhalation technique errors, and (3) adhering/not adhering to medication will be examined in a multivariable linear mixed model.

Ethics: The study protocol was approved by ethics committees/institutional review boards of all participating sites prior to enrolment; written informed consent was obtained from all study participants.

Trial registration number: ClinicalTrials.gov: NCT04532853.

Keywords: Chronic airways disease; Primary care; Protocols and guidelines; Quality in healthcare; Respiratory medicine.

Associated data

ClinicalTrials.gov/NCT04532853